Effect of Vitamin E on Non-Alcoholic Fatty Liver Disease
Completed · Not applicable · Has a placebo group
Conditions studied: Healthy, NAFLD (Non-Alcoholic Fatty Liver Disease), NASH (Non-Alcoholic Steatohepatitis)
In brief
One-third of the US population has non-alcoholic fatty liver disease (NAFLD) due to obesity and \~8 million of these individuals have a progressive form of the disease, non-alcoholic steatohepatitis (NASH). Currently, there are no noninvasive ways to determine which individuals with NAFLD will develop NASH. This is of medical importance since NASH can be a prelude to the development of end-stage liver disease. The study of NAFLD has been limited by several factors, including the difficulties associated with studying liver metabolism in vivo in humans. Our group has pioneered new methods that use nuclear magnetic resonance (NMR) to measure intermediary hepatic metabolism in humans with a goal of directly studying the pathophysiology of bland steatosis and NASH. In this study, these noninvasive methods will be used to characterize and compare the metabolic alterations that accompany bland steatosis and NASH and test the hypothesis that detects if hepatic mitochondrial metabolism contribute to both disorders. Such characterization is fundamental to establishing a rational approach to the prevention and treatment of NAFLD and may provide simple, non-invasive methods to differentiate benign and progressive forms of NAFLD. This proposal will be addressed via separate isotopic studies occurring at different time points during a prolonged fast. In subjects with NAFLD, these studies will be carried out before and after treatment with Vitamin E or placebo. Healthy subjects will participate in initial baseline studies only without Vitamin E or placebo intervention. The study is designed to harness the physiologic changes that occur with short- and long-term fasting to provide a rapid and cost-effective method to accomplish the aims of the application.
Key facts
- Study ID
- NCT02690792
- Run by
- Jeffrey Browning
- People needed
- 70
- Starts
- 2009-12-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-11-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- NAFLD/NASH SUBJECTS
- Male and Female, Age 18-65 years of all racial and ethnic origins
- Hepatic steatosis by radiologic study with or without liver enzyme elevation
- BMI < 35 kg/m2
- English or Spanish language
- Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol
- May also have Type 2 Diabetes (T2DM) with:
- Hemoglobin A1C < 8.5 % of total Prior, current or no oral antidiabetic medication usage
- CONTROL SUBJECTS:
- Age 18-65 years.
- BMI ≤ 35 kg/m2
- English or Spanish language
- Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol
- May also have T2DM with:
- Hemoglobin A1C < 8.5 % of total Prior, current or no oral antidiabetic medication usage
You may not qualify if…
- ALL SUBJECTS:
- Diabetes type 1
- Diabetes type 2 with:
- Hemoglobin A1C < 8.5 % of total Current or prior insulin usage
- Medications or conditions that confound the diagnosis of NAFLD
- Excessive alcohol intake (>30 g/day in men and >20 g/day in women)
- Chronic liver disease other than NAFLD/NASH
- Glucocorticoids
- Medications or conditions that alter hepatic metabolism
- Autoimmune disorders
- Current or chronic infection
- Other endocrine disorders
- Recent weight loss (> 10 lbs. within the past 3 months)
- Prescription weight-loss medications
- Medical conditions likely to increase the risk of intervention Renal insufficiency (creatinine > 1.4 mg/dL) Baseline metabolic acidosis Congestive heart failure
- Conditions or behaviors likely to affect the conduct of the study Pregnancy and breastfeeding confirmed by urine pregnancy test prior to all imaging or invasive procedure such as the euglycemic clamp, stable isotope studies, as well as prior to initiation of Vitamin E.
- Concurrent participation in another research project
- Inability to accept treatment assignment
- Major psychiatric disorder or substance abuse
- CONTROL SUBJECTS (in addition to the above):
- Liver disease Elevated liver function tests Hepatic steatosis
- Metabolic syndrome Hypertriglyceridemia (fasting plasma triglycerides > 150 mg/dL). Systolic blood pressure > 140 mmHg Diastolic blood pressure > 80 mmHg
- Exercise above activities of daily living
Where it is running
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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